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High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

NCT02095847 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-08

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can be used to help guide tumor removal during a hysterectomy.

Conditions

  • Uterine Cancer

Interventions

PROCEDURE

High-Resolution Microendoscopy Imaging

Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the HRME camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.

DRUG

Proflavine

After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.

Sponsors & Collaborators

  • Ovarian Spore

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pedro Ramirez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-03-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095847 on ClinicalTrials.gov